Browse Device Recalls

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,276 FDA device recalls in 2022.

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DateProductReasonClassFirm
Aug 16, 2022 Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-14... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN TH... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, RE... impaired functionality of the release liner Class II ConvaTec, Inc
Aug 16, 2022 Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; R... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RP... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part N... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Numbe... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Referen... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part N... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, RE... impaired functionality of the release liner Class II ConvaTec, Inc
Aug 16, 2022 Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF ... impaired functionality of the release liner Class II ConvaTec, Inc
Aug 16, 2022 Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN ... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Pa... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 12, 2022 SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Ba... Potential presence of residual adhesive material on the mesh surface. Class II Chamberlain Technologies LLC
Aug 12, 2022 Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION ... An out of specification component preventing the blue retention ring from keeping the rotation kn... Class II Olympus Corporation of the Americas
Aug 12, 2022 COVID Test Kit Nonsterile Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 dev... Class II American Contract Systems, Inc.
Aug 12, 2022 Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION ... An out of specification component preventing the blue retention ring from keeping the rotation kn... Class II Olympus Corporation of the Americas
Aug 12, 2022 Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mob... Due to un-commanded movement of mobile x-ray unit. Class II SEDECAL SA
Aug 12, 2022 SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number... Potential presence of residual adhesive material on the mesh surface. Class II Chamberlain Technologies LLC
Aug 12, 2022 EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component. Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner impl... Class II Encore Medical, LP
Aug 12, 2022 SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Ca... Potential presence of residual adhesive material on the mesh surface. Class II Chamberlain Technologies LLC
Aug 12, 2022 Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION ... An out of specification component preventing the blue retention ring from keeping the rotation kn... Class II Olympus Corporation of the Americas
Aug 12, 2022 Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark... There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p... Class II CooperSurgical, Inc.
Aug 12, 2022 Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark... There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p... Class II CooperSurgical, Inc.
Aug 12, 2022 SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog ... Potential presence of residual adhesive material on the mesh surface. Class II Chamberlain Technologies LLC
Aug 12, 2022 EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Or... Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner impl... Class II Encore Medical, LP
Aug 12, 2022 DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors Procedure packs contained a recalled product. Class II DeRoyal Industries Inc
Aug 11, 2022 GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... Class II Exactech, Inc.
Aug 11, 2022 GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... Class II Exactech, Inc.
Aug 11, 2022 IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI)... An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunog... Class II Siemens Healthcare Diagnostics, Inc.
Aug 11, 2022 GXL acetabular liners, orthopedic hip implant component. Product Line Number... Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... Class II Exactech, Inc.
Aug 11, 2022 GXL acetabular liners, orthopedic hip implant component. Product Line Number... Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... Class II Exactech, Inc.
Aug 11, 2022 GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... Class II Exactech, Inc.
Aug 11, 2022 GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... Class II Exactech, Inc.
Aug 11, 2022 GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... Class II Exactech, Inc.
Aug 11, 2022 GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... Class II Exactech, Inc.
Aug 11, 2022 GXL acetabular liners, orthopedic hip implant component. Product Line Number... Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... Class II Exactech, Inc.
Aug 11, 2022 GXL acetabular liners, orthopedic hip implant component. Product Line Numbe... Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impac... Class II Exactech, Inc.
Aug 10, 2022 VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55... OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimens... Class II Angiodynamics, Inc.
Aug 10, 2022 Artis pheno- Model No. 10849000 Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and... Class II Siemens Medical Solutions USA, Inc
Aug 10, 2022 Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis... Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and... Class II Siemens Medical Solutions USA, Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.